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Learning Track

Medical Devices

This 4-day track provides participants with the foundation for effectively using statistical methods to analyze, improve, and validate medical device processes.

It is appropriate for process engineers, R&D team members, and other quality professionals who need to understand how to apply statistical tools to a medical device process.

Explore the data analysis techniques necessary to understand variation and defects, claim equivalence, conduct multi-vari studies, determine the useful life of a product, evaluate and certify measurement systems, validate a process is capable of meeting customer specifications, and monitor the stability of a validated process. Emphasis is placed on all applications that will help you make sound business decisions to ensure you are providing the best quality product to your customers.

Statistical principles will be presented through case studies, examples, and exercises ― all supported by Minitab Statistical Software.

DAYS 1-2

Statistical Tools for Medical Devices - Minitab Essentials

In this 2-day foundational course you will learn to minimize the time required for data analysis by using Minitab to import data, develop sound statistical approaches to exploring data, create and interpret compelling graphs, and export results. Analyze a variety of real-world medical device data sets to learn how to align your applications with the right statistical tool and interpret statistical output to reveal problems with a process or evidence of an improvement. Learn the fundamentals of important statistical concepts, such as hypothesis testing and confidence intervals, and how to uncover and describe relationships between variables with statistical modeling tools.

This course places a strong emphasis on making sound decisions based upon the practical application of statistical techniques commonly found in the medical device industry.

Topics Include:

  • Importing and Formatting Data
  • Bar Charts
  • Histograms
  • Boxplots
  • Pareto Charts
  • Scatterplots
  • Tables and Chi-Square Analysis
  • Measures of Location and Variation
  • t-Tests
  • Proportion Tests
  • Tests for Equal Variance
  • Equivalence Tests
  • Power and Sample Size
  • Correlation
  • Simple Linear and Multiple Regression
  • One-Way ANOVA
  • Multi-Variable ANOVA

Participants of the course will be able to:

  • Easily organize and visualize data
  • Make decisions about process parameters using statistical methods
  • Use Regression to model variable relationships

Prerequisites: None

Audience: Scientists, R&D Engineers, Quality Engineers, Operational Excellence Professionals

DAY 3

Statistical Tools for Medical Devices - Statistical Quality Analysis

Develop the necessary skills to successfully evaluate and certify measurement systems. Learn the fundamentals of statistical process control and how these important quality tools can provide the necessary evidence to improve and control medical device processes. Develop the skills to know when and where to use the various types of control charts available in Minitab for your own processes. Learn how to utilize important capability analysis tools to validate your processes relative to internal and customer specifications.

The course emphasis is placed on teaching quality tools as they relate to medical device processes.

Topics Include:

  • Gage R&R
  • Destructive Testing
  • Gage Linearity and Bias
  • Attribute Agreement
  • Variables and Attribute Control Charts
  • Capability Analysis for Normal, Nonnormal, and Attribute data
  • Acceptance Sampling

Participants of the course will be able to:

  • Determine the acceptability of a measurement system using industry standards
  • Monitor process parameters using the appropriate control chart
  • Use Cpk and Ppk to validate a process relative to customer requirements

Prerequisites: Statistical Tools for Medical Devices - Minitab Essentials

Audience: Scientists, R&D Engineers, Process Engineers, Operational Excellence Professionals

DAY4 

Statistical Tools for Medical Devices - Factorial Design

Learn to generate a variety of full and fractional factorial designs using Minitab’s intuitive DOE interface. Real-world medical device applications demonstrate how the concepts of randomization, replication, and blocking form the basis for sound experimentation practices. Develop the skills necessary to correctly analyze the resulting data to effectively and efficiently reach experimental objectives.

Use Minitab’s customizable and powerful graphical displays to interpret and communicate experimental results to improve products and processes, find critical factors that impact important response variables, reduce process variation, and expedite research and development projects.

Topics Include:

  • Design of Factorial Experiments
  • Normal Effects Plot and Pareto of Effects
  • Power and Sample Size
  • Main Effect, Interaction, and Cube Plots
  • Center Points
  • Overlaid Contour Plots
  • Multiple Response Optimization

Participants of the course will be able to:

  • Understand the difference between full factorial and fractional factorial designs
  • Use statistical modeling to uncover the important effects and interactions
  • Determine optimal settings using graphical and numerical optimization tools

Prerequisites: Statistical Tools for Medical Devices- Minitab Essentials

Audience: Scientists, R&D Engineers, Process Engineers, Operational Excellence Professionals

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